AVALIDE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Dostępny od:

SANOFI-AVENTIS CANADA INC

Kod ATC:

C09DA04

INN (International Nazwa):

IRBESARTAN AND DIURETICS

Dawkowanie:

300MG; 25MG

Forma farmaceutyczna:

TABLET

Skład:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

90

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0240086003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2017-07-17

Charakterystyka produktu

_AVALIDE Product Monograph _
_Page 1 of 42_
PRODUCT MONOGRAPH
Pr
AVALIDE
®
(Irbesartan/hydrochlorothiazide Tablets, USP)
150/12.5 mg, 300/12.5 mg and 300/25 mg Tablets
Angiotensin II AT
1
Receptor Blocker / Diuretic
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
May 8, 2017
Submission Control No.: 203641
s-a Version dated May 8, 2017
_AVALIDE Product Monograph _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
....................................................................................
27
PHARMACEUTICAL INFORMATION
....................................................